NCT02934425

Effects of Lean Pork, High Protein Breakfast on Satiety and Metabolic Health in Pre-diabetes

A Randomized, Controlled, Crossover Trial to Assess the Effects of a Lean Pork-containing, High-protein Breakfast on Indices of Satiety and Metabolic Health in Men and Women With Pre-diabetes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Midwest Center for Metabolic and Cardiovascular Research · Academic / Other
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to assess the effects of consumption of a lean pork-containing, high-protein breakfast versus a refined carbohydrate-rich breakfast on satiety and cardiometabolic parameters in overweight or obese adults with pre-diabetes.

Detailed description

This is a randomized, crossover trial that includes two screening visits, one baseline visit, and two test periods of 2 weeks each, each ending with a test visit, separated by a 2-week washout. Subjects consume each day a refined carbohydrate-rich breakfast containing 8/66/26% kcal from protein/carbohydrate/fat, respectively (Control Condition), or a high pork protein breakfast containing 35/39/26% kcal from protein/carbohydrate/fat, respectively (Active Condition). Study products for daily breakfast consumption will be dispensed to the subjects at the beginning of each test period. Subjects will complete 3-day diet records at baseline and the end of each test period, and a daily Appetite Visual Analog Scale (VAS) Diary to asses perceived hunger and fullness each evening before retiring throughout each test period. VAS assessments of hunger, fullness, desire to eat, prospective food consumption, focus and energy will also be assessed at the clinic visit at the end of each test period, pre- and post-breakfast consumption (multiple time points). Subjects will also complete a palatability questionnaire at the each of each test period. Blood samples will be collected at fasting at baseline and pre- and post-breakfast consumption (multiple sampling) at the end of each test period to evaluate glucose, insulin, and lipoprotein lipid concentrations.

Conditions

• Pre-diabetes

Interventions

Type	Name	Description
OTHER	Refined carbohydrate-rich breakfast	Refined carbohydrate-rich breakfast containing approximately 8/66/26% kcal from protein/carbohydrate/fat, respectively
OTHER	High pork protein breakfast	High pork protein breakfast containing approximately 35/39/26% kcal from protein/carbohydrate/fat, respectively

Timeline

• Start date: 2016-08-01
• Primary completion: 2017-02-01
• Completion: 2017-02-01
• First posted: 2016-10-17
• Last updated: 2018-05-15

Locations

1 site across 1 country: United States